JP2019037631A - Seal material and container - Google Patents

Abstract

To provide a means of facilitating detecting a fact that a foreign material is mixed in a container body from a port, or a trial to mix a foreign material is performed, by punctuating a seal material of a medicine container with a needle-like article.SOLUTION: A seal material 1 covers an opening of a container body for storing a content. The seal material includes: a sealant layer 16 which peelably adheres to the circumference of the opening; and a deformation layer 19 which is formed at a surface side opposite to a surface facing the opening of the sealant layer, and in which plastic deformation due to puncture with a needle-like article and/or needle removal thereafter is generated.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a sealing material and a container.

  Conventionally, infusion has been widely used for the purpose of water / electrolyte replenishment, nutritional replenishment, blood vessel securing, pathological treatment and the like. The infusion solution is used by being contained in an infusion bag, and the infusion bag generally has a container body containing the infusion solution and a port for discharging the infusion solution. Inside the port is a sealing body such as a rubber stopper to prevent the infusion from flowing out. The port opening is covered with a sealing material, and at least part of the sealing material is peeled off when the infusion bag is used. Is done.

  If the infusion contains amino acids or certain antibiotics, the port must be able to protect against oxygen ingress because it is susceptible to oxygen, and infusion containing certain drugs will maintain a dissociation equilibrium Therefore, the space in the port (head space) between the sealing body and the sealing material may be replaced with nitrogen gas. Even when the infusion solution is not of a special composition, the opening of the port is usually covered with a sealing material for the purpose of cleaning the inside of the port. Thus, in the infusion bag, it is necessary to keep the sealed state by covering the port with the sealing material, and when the sealed state is impaired, it is necessary to detect it from the outside.

  As an infusion bag capable of detecting a sealed state, for example, a gas detector is arranged in the head space so that the reaction of the gas detector when the sealing property is impaired can be visually confirmed from the outside. Is known (for example, Patent Document 1).

JP 2005-349182 A

  In recent years, there have been incidents of intentional foreign body contamination from the port to the inside of the infusion bag, and there is an increasing need to easily detect foreign body contamination before prescribing the human body. .

  Therefore, the object of the present invention is to puncture the sealing material of the container with a needle-like object or the like, so that even if a foreign body is mixed in the container body or an attempt is made to mix the foreign object, It is to provide a means for detecting facts.

  The present invention is a sealing material that covers an opening of a container main body that contains contents, and has a sealant layer that is detachably bonded to the periphery of the opening, and a surface opposite to the surface of the sealant layer that faces the opening. There is provided a sealing material comprising: a deformed layer formed on the surface side and causing plastic deformation by puncture with a needle-like object and / or subsequent needle removal.

  Since the sealing material of the present invention has the above-described configuration, for a container whose opening is covered with this sealing material, when a foreign material is mixed into the container body by puncturing the sealing material, an attempt has been made to mix the foreign material. Even in this case, the fact can be easily detected by plastic deformation of the deformation layer.

  The opening may be formed at the other end of the outflow port for the contents whose one end is connected to the container body. That is, the present invention is a sealant that covers the other end of the medicine inflow / outflow port, one end of which is connected to a container body that contains the medicine, and is a sealant layer that is peelably bonded to the other end. And a deformation layer that is formed on the surface of the sealant layer opposite to the surface in contact with the port and generates plastic deformation by puncturing with needles and / or subsequent needle removal. .

  According to the sealing material, even when foreign matter is mixed into the container body from the port or when an attempt is made to mix foreign matter, it can be easily performed by puncturing the sealing material of the container with a needle-like object or the like. This fact can be detected. A person who intentionally mixes a foreign object does not puncture the container body directly, but mixes the foreign object into the container body from the port side in order to eliminate the trace of the contamination. That is, when the container body is punctured with a needle-like object such as a needle, the drug leaks after the needle is removed, so the needle-like object is removed from the sealing material and the sealing body (with the sealing material attached to the port). The rubber stopper is pierced and penetrated, foreign matter is mixed inside the container body, and then the needle is removed. If the size of the perforation resulting from the withdrawal of the needle is small or unnoticeable, medical personnel may misunderstand that it is unused because the sealing material is still stuck, and may use it as it is. is there.

  Since the sealing material of the present invention includes a deformed layer that undergoes plastic deformation by puncture with a needle-like object and subsequent needle removal, when the needle-like object is pierced for foreign matter contamination, the shape of the needle-like object is increased. Deformation occurs and its shape is fixed. Further, the shape is also fixed with respect to the deformation of the sealing material that occurs when the needle-shaped object is pulled out. Therefore, when foreign matter is mixed into the container body from the port or when an attempt is made to mix foreign matter, it can be easily recognized that an abnormality has occurred.

  The sealing material may include a flexible layer that is more flexible than the sealant layer between the sealant layer and the deformable layer. With such a configuration, the flexibility of the entire sealing material is improved, and pinholes and the like are prevented from being generated in the sealing material when the container comes into contact with a secondary outer bag such as a barrier bag. In addition, by providing the flexible layer between the sealant layer and the deformable layer, the shape change due to plastic deformation of the deformable layer is further maintained as compared with the case where the flexible layer is not provided. The flexibility of the layers can be compared by Young's modulus.

  The sealing material may include a protective layer that covers the deformable layer. Due to the presence of the protective layer, the sealing material can be stiff and mechanical suitability can be improved. Further, since the surface of the deformable layer is covered, it is possible to prevent the generation of pinholes.

  The deformation layer is preferably made of metal. Metal is excellent in plastic deformability, and the trace of contamination by foreign matter remains clearly even after the withdrawal of the needle, so that it can be easily detected that foreign matter has been mixed in or attempted.

  In addition to the sealing material described above, the present invention also provides a container. That is, the present invention provides a container in which the opening of a container main body that contains contents is covered with a sealing material, and the sealing material provides the above-described seal. The present invention is also a container comprising a container main body that contains a medicine as a content, and a port that has one end connected to the container main body and allows the medicine to flow in and out, the other end of the port being the sealing material described above A container (corresponding to a “medicine container”) coated with is provided.

  The sealing material of the present invention can also be applied to seal the opening of drug containers such as vials and food containers such as jelly, tofu, instant coffee bottles and supplement bottles.

  Since the opening of the container is covered with the sealing material of the present invention, when the foreign material is mixed into the container body from the opening or when an attempt is made to mix the foreign material, the sealing material is plastically deformed and punctured. Since a trace remains, the fact can be easily detected visually.

  According to the present invention, by puncturing the sealing material of the container with a needle-like object or the like, even if a foreign substance is mixed in the container body or an attempt is made to mix a foreign substance, the fact is easily confirmed. A detectable means can be provided.

It is a top view of the medicine container of a 1st embodiment. It is sectional drawing of the part shown by A of FIG. It is sectional drawing of the sealing material of 1st Embodiment. It is sectional drawing which shows the place where the puncture by the needle was performed from the port. It is sectional drawing of the sealing material of 2nd Embodiment. It is sectional drawing of the sealing material of 3rd Embodiment. It is sectional drawing of the sealing material of 4th Embodiment. It is a top view of the chemical | medical agent container of 2nd Embodiment.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. In this description, the same reference numerals are used for the same elements, and duplicate descriptions are omitted. In addition, the dimensional ratio in each drawing does not necessarily match the actual dimensional ratio.

  FIG. 1 is a top view of a container (corresponding to the drug container of the first embodiment as described later) including a container body and a port covered with a sealing material, and FIG. 2 is indicated by A in FIG. FIG. A drug container 30 shown in FIG. 1 includes a container main body 34 that contains a drug 32, a port 20 having one end connected to the container main body 34, and a sealing material 1 that covers the other end of the port 20. The port 20 includes a cylindrical portion 22 and a mouth portion 24, and a sealing body 26 for preventing the medicine 32 from flowing out is disposed inside the port 20 as shown in FIG.

  FIG. 3 is a cross-sectional view of the sealing material of the first embodiment. The sealant 1 shown in FIG. 3 includes a sealant layer 16 that is detachably bonded to the other end of the port 20, and a deformation layer formed on the surface side of the sealant layer 16 opposite to the surface in contact with the other end of the port 20. 19. The deformation layer 19 causes plastic deformation by puncture with a needle-like object and / or subsequent needle removal. Note that an adhesive layer for adhering these layers may be provided between the sealant layer 16 and the deformation layer 19.

  FIG. 4 is a cross-sectional view showing a state where puncture with a needle is performed from the port 20. In FIG. 4, the foreign material 42 is introduced into the inside of the syringe 40 composed of the syringe main body 44 and the needle 46, and the foreign material 42 is mixed using this. The needle 46 penetrates the sealant layer 16 and the deformation layer 19, and foreign matter 42 is mixed inside the container body 34. When the needle 46 penetrates the sealing material 1, the sealant layer 16 and the deformation layer 19 are pushed by the needle 46 and deformation occurs in the penetration direction. This deformation is fixed even after the needle 46 is pulled out. . When the needle 46 is pulled out, if the needle 46 is pulled out at an angle, further plastic deformation of the sealing material 1 occurs along the pulled-out direction. Since the portion where the composition deformation has occurred is visible, the fact of contamination can be easily detected.

  FIG. 5 is a cross-sectional view of the sealing material of the second embodiment. The sealing material 1 shown in FIG. 5 includes a flexible layer 52 between the sealant layer 16 and the deformation layer 19. The flexible layer 52 provides flexibility to the entire sealing material 1. The soft layer 52 is a softer layer (for example, a layer having a lower Young's modulus) than the sealant layer 16, and between the sealant layer 16 and the soft layer 52 and between the soft layer 52 and the deformable layer 19. You may provide the contact bonding layer which adhere | attaches a layer.

  FIG. 6 is a cross-sectional view of the sealing material of the third embodiment. The sealing material 1 shown in FIG. 6 has a configuration in which a deformation layer 19 is laminated on the sealant layer 16 and a protective layer 14 is laminated on the deformation layer 19. The protective layer 14 gives the whole sealing material 1 stiffness and imparts mechanical suitability. In addition, when the sealing material 1 comes into contact with something other than a needle-like material for mixing foreign matter, the deformation layer 19 also has a function of preventing plastic deformation and defects such as pin holes in the sealing material 1. An adhesive layer that bonds these layers may be provided between the sealant layer 16 and the deformation layer 19 and between the deformation layer 19 and the protective layer 14.

  FIG. 7 is a cross-sectional view of the sealing material of the fourth embodiment. The sealing material 1 shown in FIG. 7 has a configuration in which a sealant layer 16, a flexible layer 52, a deformation layer 19, and a protective layer 14 are laminated in this order. The functions of the flexible layer 52 and the protective layer 14 are as described above. Between the sealant layer 16 and the flexible layer 52, between the flexible layer 52 and the deformable layer 19, and between the deformable layer 19 and the protective layer 14, You may provide the contact bonding layer which adhere | attaches a layer.

  The sealant layer 16 can be formed of, for example, a polymer substance, for example, a polyolefin such as polyethylene or polypropylene, and the deformable layer 19 is, for example, a metal such as aluminum, paper, cellulose, a resin having shape memory property, or the like. Can be formed. The flexible layer 52 can be formed of, for example, a polyamide resin such as 6,6-nylon (registered trademark), a polymer material such as ethylene vinyl alcohol copolymer (EVOH), polyethylene, and the protective layer 14 is formed of, for example, , Polyethylene terephthalate, polybutylene terephthalate, polypropylene, nylon, and other polymer materials. The protective layer 14 may be a single layer or a laminate composed of a plurality of layers. When the sealing material 1 has an adhesive layer, the adhesive layer can be formed of a urethane adhesive, an acrylic adhesive, a synthetic rubber adhesive, an epoxy adhesive, or the like.

  The thickness of the sealant layer 16, the deformation layer 19, the flexible layer 52, and the protective layer 14 is arbitrary, but the sealant layer 16 is 10 to 150 μm, the deformation layer 19 is 5 to 100 μm, and the flexible layer 52 is 10 The protective layer 14 can be 10 to 100 μm. Although the thickness of the whole sealing material 1 is also arbitrary, in order to ensure the effect of the present invention, the thickness can be set to, for example, 50 to 300 μm, and more preferably 50 to 110 μm. The material and thickness of the deformation layer 19 are preferably selected so as to have holdability when a needle having a diameter of 0.4 to 1.2 mm is stabbed.

  The sealing material according to the first to fourth embodiments can be manufactured by individually manufacturing each layer constituting the sealing material and thermally laminating the whole, and can also be manufactured by a known method.

  A drug container can be provided using the sealing material described above. FIG. 1 is a top view showing such a drug container. A drug container 30 according to the first embodiment shown in FIG. 1 includes a container main body 34 for storing a drug 32, and a port 20 having one end connected to the container main body 34 and allowing the drug 32 to flow in and out. The other end of the port 20 is And the sealing material 1 of the embodiment. The port 20 includes a sealing body 26 for preventing the medicine 32 from flowing out. The drug container 30 of the first embodiment corresponds to a single-chamber bag because there is one container (medicine container) that stores the drug 32.

  FIG. 8 is a top view showing the container (drug container 30) of the second embodiment. The medicine container 30 shown in FIG. 8 has two accommodation parts (drug accommodation parts) for accommodating medicines, that is, the first medicine 32a is separated from the port 20 in the first medicine accommodation part on the port 20 side. Except for storing the second drug 32b in the second drug container on the side, it has the same configuration as the drug container of the first embodiment. The first drug container and the second drug container are partitioned by a weak seal portion 36 having easy peelability, and the weak seal portion 36 is peeled immediately before the drug container 30 is used, so that the first drug is separated. 32a and the second medicine 32b are mixed. Note that the sealing material 1 of the embodiment can be applied even if the medicine container has three or more.

  In the drug containers of the first and second embodiments, the drug 32, the first drug 32a, and the second drug 32b accommodated in the container body 34 include an electrolyte solution (saline solution, Ringer's solution), glucose solution, and amino acid solution. , Vitamin liquid, trace element liquid, and the like. The drug may be liquid or non-liquid (solid, etc.).

  The container body 34 can be composed of a polymer film having excellent heat resistance, sealing strength, transparency, moisture permeability, flexibility, etc., and this polymer film may be a laminate for improving the performance. . Examples of the polymer used in the polymer film include olefin homopolymers or copolymers, copolymers of olefin and a compound having an ethylenically unsaturated bond other than olefin, and compounds having an ethylenically unsaturated bond other than olefin. A homopolymer or a copolymer may be mentioned. As an example of the olefin copolymer, there is an ethylene / α-olefin copolymer, and the container body 34 may be configured by a laminate in which a plurality of ethylene / α-olefin copolymers having different densities are stacked. .

  The port 20 includes a mouth portion 24, a tubular portion 22 fitted into one end of the mouth portion 24, and a sealing body 26 that is disposed in close contact with the inside of the tubular portion 22 and prevents the medicine 32 from flowing out. The The other end of the mouth 24 is covered with the sealing material 1 so as to cover the opening. The cylindrical portion 22 is bonded (tightly bonded) to the container main body 34 without a gap, but the members constituting the cylindrical portion 22 and the innermost layer constituting the container main body 34 are made of the same resin and are closely bonded by heat sealing or the like. It is preferable to do.

  The port 20 can be manufactured by inserting the sealing body 26 into the upper portion of the cylindrical portion 22 and then pressing and fitting the mouth portion 24 against the sealing body 26 using a heated jig. Moreover, adhesion | attachment to the opening part 24 of the sealing material 1 is realizable by adhesion | attachment by heat sealing or adhesive application.

  As a manufacturing method of the medicine container 30 of the first embodiment, there are the following methods. That is, for a set of polymer films constituting the container body 34, the peripheral portions of the three sides other than the side where the port 20 is inserted are heat-sealed. Subsequently, after inserting the cylindrical part 22 in the location which is not heat-sealed, the cylindrical part 22 and a polymer film are heat-sealed and it adheres without a gap. After filling the inside of the container body 34 with the medicine 32 through the cylindrical portion 22 and inserting the sealing body 26 into the upper portion of the cylindrical portion 22, the mouth 24 is made to the sealing body 26 using a heated jig. Press to fit. Next, the sealing material 1 is heat-sealed to the mouth portion 24 or bonded by applying an adhesive.

  Other manufacturing methods for the drug container 30 of the first embodiment include the following methods. That is, the cylindrical portion 22 is sandwiched between a pair of polymer films constituting the container main body 34 and bonded without a gap by heat sealing. Subsequently, after inserting the sealing body 26 into the upper part of the cylindrical part 22, the opening part 24 is pressed and fitted with respect to the sealing body 26 using the heated jig | tool, and the sealing material 1 is attached to the opening part 24. Heat seal or adhere with adhesive. At the same time or after this, the peripheral portions of the remaining three sides are heat-sealed, leaving one side where the port 20 is not inserted. The medicine 32 is filled into the container body 34 from one side that is not heat-sealed, and then this side is heat-sealed.

  Since the medicine container 30 according to the embodiment covers the port 20 with the sealing material 1, the sealing material is used when a foreign substance is mixed into the container body 34 from the port 20 or when an attempt is made to mix the foreign substance. Since the shape is fixed while 1 is deformed, the medicine container 30 in which foreign matter is mixed or tried to be mixed is not mistakenly used as a normal product and is not used.

DESCRIPTION OF SYMBOLS 1 ... Sealing material, 14 ... Protective layer, 16 ... Sealant layer, 19 ... Deformation layer, 20 ... Port, 22 ... Cylindrical part, 24 ... Mouth part, 26 ... Sealing body, 30 ... Drug container, 32 ... Drug, 32a ... 1st chemical | medical agent, 32b ... 2nd chemical | medical agent, 34 ... Container main body, 36 ... Weak seal part, 40 ... Syringe, 42 ... Foreign material, 44 ... Syringe main body, 46 ... Needle, 52 ... Flexible layer.

Claims (7)

A sealing material that covers the opening of the container body that contains the contents,
A sealant layer that is releasably bonded to the periphery of the opening, and plastic deformation by puncturing with a needle-like object and / or subsequent needle removal formed on the surface of the sealant layer opposite to the surface facing the opening And a deformable layer.   The sealing material according to claim 1, wherein the opening is formed at the other end of the outflow port for the contents whose one end is connected to the container body.   The sealing material according to claim 1, further comprising a flexible layer that is more flexible than the sealant layer between the sealant layer and the deformation layer.   The sealing material as described in any one of Claims 1-3 provided with the protective layer which coat | covers this layer on the said deformation | transformation layer.   The sealing material according to claim 1, wherein the deformation layer is made of metal. A container in which an opening of a container body for storing contents is covered with a sealing material,
The said sealing material is a container which is a sealing material as described in any one of Claims 1-5. A container comprising a container main body that contains a medicine as a content, and a port that is connected to one end of the container main body and allows the medicine to flow in and out,
The container with which the other end of the said port is coat | covered with the sealing material as described in any one of Claims 2-5.

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